Biopharmaceutical Characterisation of Herbal Medicinal Products
The FIP Special Interest Group (SIG) Quality of Pharmaceuticals established in 1999 a working group aiming to elaborate recommendations for biopharmaceutical characterisation of Herbal Medicinal Products (HMPs). Considering the current European and international regulatory guidelines on quality for HMP it was felt there is the need for clarification of biopharmaceutical characteristics taking into account a new classification of HMPs. A first draft was published in Pharm. Ind. 63 (10), 1005 (2001), and Pharmacop. Forum 28 (1), 173 (2002).
Comments were meanwhile collected by the authors and integrated into the present final version as far as possible. A scientific symposium dedicated to the topic was organised at Berlin by the German Pharmaceutical Society. Due to the complexity of the matter not all scientific views could be harmonised. The publication is now updated and substantially extended. The items pharmaceutical equivalence of plant extracts and their dissolution from the pharmaceutical formulation are clarified and integrated into the concept. Further aspects of the solubility of plant extracts have been elaborated. The decision trees are simplified and put in more concrete terms. The index on literature is extended.
The FIP working group would like to emphasize the stipulating character of the present proposals as a discussion paper and not binding recommendations.
The group is aware that Herbal Medicinal Products are not in all cases and countries regarded as part of the science based medicine. Often plant extracts are used in form of dietary supplements and food products. This publication mainly aims at scientifically accompanied and accepted HMPs. The FIP Working group Herbal Medicinal Products (HMP) consists of the following experts: Dr. Friedrich Lang (Dr. Willmar Schwabe Arzneimittel, Karlsruhe, Germany, chair of the group), Prof. Dr. Konstantin Keller (Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany), Dr. Michael Ihrig (Zentrallaboratorium Deutscher Apotheker, Eschborn, Germany), Joy van Oudtshoorn-Eckard (J & B Pharmaceutical Consultants, Pretoria, South Africa), Prof. Dr. Helga Möller (Zentrallaboratorium Deutscher Apotheker, Eschborn, Germany), Dr. Srini Srinivasan (United States Pharmacopoeia, Rockville, USA), Dr. Yu He-ci (Hankintatukku OY, Finland)